Towards a New Global Business Model for Antibiotics Global Business Model for a New Towards Chatham House Report Edited by Charles Clift, Unni Gopinathan, Chantal Morel, Kevin Outterson, John-Arne Røttingen and Anthony So Towards a New Global Business Model for Antibiotics Edited by Charles Clift, Gopinathan, and Anthony John-ArneSo Outterson, Charles Chantal Unni Kevin Røttingen by Morel, Edited Delinking Revenues from Sales Report from the Chatham House Working Group on New Antibiotic Business Models Chatham House Chatham House Report Edited by Charles Clift, Unni Gopinathan, Chantal Morel, Kevin Outterson, John-Arne Røttingen and Anthony So October 2015 Towards a New Global Business Model for Antibiotics Delinking Revenues from Sales Report from the Chatham House Working Group on New Antibiotic Business Models Chatham House, the Royal Institute of International Affairs, is an independent policy institute based in London. Our mission is to help build a sustainably secure, prosperous and just world. The Royal Institute of International Affairs Chatham House 10 St James’s Square London SW1Y 4LE T: +44 (0) 20 7957 5700 F: + 44 (0) 20 7957 5710 www.chathamhouse.org Charity Registration No. 208223 © The Royal Institute of International Affairs, 2015 Chatham House, the Royal Institute of International Affairs, does not express opinions of its own. The opinions expressed in this publication are the responsibility of the authors. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including photocopying, recording or any information storage or retrieval system, without the prior written permission of the copyright holder. Please direct all enquiries to the publishers. ISBN 978 1 78413 057 2 A catalogue record for this title is available from the British Library. 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Cover image © Yuri Smityuk/ITAR-TASS Photo/Corbis High-level complex of physiologically active antibiotic substance extracted from blastema at the Arctic Innovation Center (AIC) of Ammosov, North-Eastern Federal University (NEFU) in Yakutsk. ii | Chatham House Contents About the Editors iv Working Group Members and Observers v Acknowledgments v Glossary vi Executive Summary and Recommendations vii 1 Introduction 1 2 What Kind of Funding and Incentive Schemes Might Work? 3 3 Which Products Should Be Covered? 12 4 How Could Funding Be Raised? 15 5 What is the Role of Intellectual Property? 18 6 How Can New Incentives Be Reconciled with Rational Use of Antibiotics? 21 7 How Can a New Scheme Be Applied Regionally and Globally? 25 8 Concluding Comments and Recommendations 30 References 32 Chatham House | iii About the Editors Charles Clift is a senior consulting fellow in the Centre on American Journal of Law & Medicine. His co-authored blog Global Health Security at Chatham House. Previously he on health economics is viewed by more than one million was an economist at the UK Department for International readers per year. Development. In addition to his work for Chatham House, John-Arne Røttingen is the Director of the Division of he has been a consultant to UNITAID, the World Intellectual Infectious Disease Control at the Norwegian Institute of Property Organization, the Access to Medicine Foundation Public Health; Professor of Health Policy at the Institute and the World Health Organization (WHO). He is also chair of Health and Society, University of Oslo; and Adjunct of the board of the Medicines Patent Pool Foundation. Professor of Global Health at the Harvard School of Public Unni Gopinathan is a medical intern at Akershus University Health. He is an associate fellow of the Centre on Global Hospital and a PhD candidate at Oslo University Hospital/ Health Security, Chatham House; research associate of the University of Oslo. He received his MD from the University European Observatory on Health Systems and Policies; of Oslo. He has previously been a Duke Global Health Fellow and chair of the board of the Alliance for Health Policy and at the Geneva Program organized by Duke University’s Systems Research. He received his MD and PhD from the Sanford School of Public Policy, Liaison Officer to the University of Oslo, his MSc from Oxford University and WHO for the International Federation of Medical Students his MPA from Harvard University. Associations (IFMSA), and worked as a research assistant Anthony So is Professor of the Practice of Public Policy for the Lancet–University of Oslo Commission on Global and Global Health and Director of the Program on Global Governance for Health, hosted by the Institute of Health Health and Technology Access at Duke University’s Sanford and Society, University of Oslo. His interest in R&D, access School of Public Policy and the Duke Global Health and conservation of antibiotics comes from many years of Institute. He also oversees the Strategic Policy program active engagement in the student organization Universities of ReAct–Action on Antibiotic Resistance, served on the Allied for Essential Medicines. Lancet Infectious Diseases Commission on Antibiotic Chantal Morel is a Research Officer at the London School Resistance and the Institute of Medicine’s Committee on of Economics and Scientific Adjunct at the University Accelerating Rare Disease Research and Orphan Product of Geneva Medical School. Previously she worked as Development, chaired a WHO expert working group on a research fellow at the London School of Hygiene & fostering innovation to combat antimicrobial resistance, Tropical Medicine. Her work is in market analyses, pricing, and was part of the Antibiotic Resistance Working Group framework comparisons for R&D incentives in drugs and of the US President’s Council of Advisors in Science and diagnostics, and cost-effectiveness of alternative prevention Technology. Trained in internal medicine at the Hospital and treatment interventions in diseases affected by of the University of Pennsylvania, he earned his MPA as a microbial resistance. Woodrow Wilson Scholar at Princeton University, completed his fellowship as a Robert Wood Johnson Clinical Scholar Kevin Outterson is a Professor of Law and the N. Neal Pike at UCSF/Stanford, and studies antibiotic innovation as a Scholar in Health and Disability Law at Boston University, current recipient of the Robert Wood Johnson Investigator where he co-directs the Health Law Program. He is an Award in Health Policy Research. associate fellow at the Centre on Global Health Security at Chatham House. He serves on the CDC Antimicrobial Resistance Working Group and the Advisory Panel for the Longitude Prize for a rapid point-of-care diagnostic to reduce unnecessary use of antibiotics. He is involved in numerous global projects relating to antibiotic resistance, including DRIVE-AB. He is editor-in-chief of the Journal of Law, Medicine & Ethics and the faculty co-editor of the iv | Chatham House Working Group Members Acknowledgments and Observers The working group consisted of the following members: Many people contributed to this report, beginning James Anderson, Manica Balasegaram, Helen Boucher, with the participants in the roundtable organized on 2 Dan Burgess, Kalipso Chalkidou, Greg Daniel, David October 2013 by Chatham House on ‘Aligning Incentives Findlay, Ed Godber, Marie-Paule Kieny, John Rex, Ursula for Antibiotic Development and Use with Public Health Theuretzbacher, Patrick Vink. Needs’, from which the idea of a working group emerged. Thanks are due to those who contributed as working group In addition the following were observers who played a less members or observers; to the team of Chatham House direct part in the process: Christine Ardal, Claire Boville, editors, particularly Margaret May; and to the Hôpitaux Meindert Boysen, Marco Cavaleri, Greg Daniel, Nils Universitaires de Genève (HUG) for providing a room for Daulaire, Karen Grosser, Lauri Hicks, Aidan Hollis, Alison the final meeting of the working group. Valuable research Holmes, Benedikt Huttner, Aaron Kesselheim, Joseph assistance was provided by Katrina Geddes. Larsen, James Love, Karolina Maciag, John Powers, Tim Reed, Steve Solomon, Ellen ‘t Hoen, A.M. Viens, Kathleen Young, Anna Zorzet. Chatham House | v Glossary Beta-lactam antibiotics layer in their walls being too thin to retain the stain A group of antibiotics that all have a beta-lactam ring as part when decolorized with an alcohol wash. Application of a of their core structure. In most cases antibacterial activity counterstain, such as safranin, gives Gram-negative bacteria occurs through the inhibition of bacterial cell wall synthesis. a red or pink colour, visible through microscopy. Penicillin, cephalosporins and carbapenems are among the Gram-positive bacteria principal -lactam antibiotics. β Bacteria with a peptidoglycan layer in the bacterial cell wall Candida thick enough to retain the violet stain during Gram-staining A yeast, and the most common cause of fungal infections after the alcohol wash step, and microscopically visible as worldwide. purple-coloured. Examples of Gram-positive bacteria are the cocci Streptococcus and Staphylococcus, and bacilli such as Carbapenems Clostridium and Listeria. A class of β-lactam antibiotics which differ in chemical structure from others such as penicillins and Gram-staining cephalosporins. They exercise broader antibacterial activity, A staining method enabling the microscopic differentiation of including against